Kornimate/medical-research-clean huggingface dataset:
the effect of acupuncture on infertility with in-vitro fertilization (ivf) patients

Conditions: Infertility

Summary: infertility is a common problem with increased incidence. in-vitro fertilization (ivf) is by far the most commonly used treatment. the success rate of ivf is still low. this study examines the effect of acupuncture on ivf pregnancy rate, as well as possible mechanisms. it is hypothesized that acupuncture can significantly increase the ivf pregnancy rate.

infertility is a common health problem in the united states with approximately 15% of women of childbearing age receiving care for this disorder. one of the most successful and commonly utilized treatment options is in-vitro fertilization (ivf). data collected by the center for disease control (cdc) and the society for assisted reproduction (sart) showed that in the year 2001, over 100,000 ivf treatment cycles were performed through the more than 400 ivf centers in the u.s. despite many recent technological advances, pregnancy rates with ivf remain limited with the most recent cdc/sart data reporting that only 27% of treatment cycles result in a live birth. acupuncture has been utilized in china for centuries to regulate the female reproductive system and has in recent years become a popular option for infertile couples in the states. though acupuncture has been studied in other infertility settings, ivf is chosen because: 1. ivf is one of the most common infertility treatments as well as the most resource intensive treatment option. therefore, an improvement in ivf success will provide the greatest benefit to patients and society. 2. ivf affords a unique opportunity to gather the most data regarding the reproductive process and to investigate putative acupuncture related physiological changes. we propose a randomized, sham controlled feasibility study on the effect of acupuncture on ivf. sixty ivf patients will be recruited into the study to accomplish the following aims: 1. to examine the feasibility of recruiting and retaining a sufficient number of patients for an adequate powered study, 2. to identify issues related to the multicenter approach that could alter study endpoints, 3. to examine the effect size of the treatment group as compared to the sham group, 4. to examine whether acupuncture is a safe procedure for women undergoing ivf, 5. to examine the effect of acupuncture on clinical ivf outcomes, and 6. to examine the physiological and psychological impact of acupuncture on ivf patients. results obtained from the study will provide necessary information for a larger, definitive study, as well as knowledge regarding the broad mechanism of acupuncture on female reproductive function.

Eligibility criteria:
inclusion criteria: * patient is undergoing in-vitro fertilization protocol (both ivf and intracytoplasmic sperm injection - icsi) * patient is acupuncture naïve. * patient has basal serum follicle-stimulating hormone (fsh) \< 10 * patient has given informed consent to participate in study exclusion criteria: * patient has had acupuncture performed previously or currently * patient has basal serum fsh of 10 or more

Keywords: ivf acupuncture pregnant
observational trial of real-world treatment utilization and effectiveness of pi3k-inhibitors in cll/sll and fl

Conditions: Lymphoma, Small Lymphocytic; Lymphoma; Lymphoma, Non-Hodgkin; Chronic Lymphocytic Leukemia; Follicular Lymphoma

Summary: this study will assess whether there are differences in effectiveness and safety outcomes among pi3k-treated patients in a real world registry, compared to patients treated in clinical trials.

phase iv, multicenter, prospective observational study in a real world (rw) setting, designed to observe the utilization and effectiveness of pi3k-inhibitor treatment, and hrqol of patients with cll/sll/fl outside the context of a clinical trial.

Eligibility criteria:
inclusion criteria: * clinical or pathological diagnosis of cll/sll according to the international workshop on chronic lymphocytic leukemia (iwcll) diagnosis guideline or pathological diagnosis of fl, for whom the investigator has decided that pi3k-inhibitor treatment is the appropriate therapy * patients previously treated with pi3k-inhibitors are eligible for this study if they: * are restarting treatment with pi3k-inhibitor at enrollment, or * restarted pi3k-inhibitor treatment within 3 treatment cycles prior to enrollment * patients newly treated with pi3k-inhibitors are eligible for this study if they: * are starting treatment with pi3k-inhibitors at enrollment, or * started on pi3k-inhibitor treatment within 3 treatment cycles prior to enrollment * ≥18 years of age at time consent is provided to participate in this study * for patients treated with pi3k-inhibitors prior to enrollment in the study, availability of documentation of previous pi3k-inhibitor treatment, including the start date of previous or current pi3k-inhibitor treatment in patient charts or medical records * patient is willing and able to provide a signed and dated institutional review board (irb)-approved informed consent form (icf) exclusion criteria: * not applicable
aetiology of temporal arteritis study

Conditions: Temporal Arteritis

Summary: giant cell arteritis (gca) is the most common vasculitis and has significant morbidity in terms of blindness, stroke, and tissue necrosis. it requires protracted treatment with high-dose steroids, and despite this there is a risk of flare during the treatment. little is known about the initial triggers for the inflammatory process, and there are no good markers of response or relapse. we will study patients referred with suspected gca to identify important components of the immune response in gca, and follow them over time to collect evidence of how best to monitor their condition.

objectives and study plan: study purpose: the purpose of the study is to investigate the underlying immunological processes in gca and to study the pattern of expression of immune response over time to give us information about how best to monitor gca. end point: the end point will be the final visit of the final patient. milestones: the project is in 3 phases. in phase 1 (0-2 years) patients will be recruited to fulfil the specified primary and secondary objectives. in phase 2 (0-4 years), these patients will be followed up for a total of 2 years each, or until they are discharged from clinic. in phase 3 (1-5 years), further studies will be defined and tissue and data collected under amended ethics.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or over 2. a clinical suspicion of a new diagnosis of gca e.g. patients with a new onset of headache, scalp tenderness, with or without elevated crp or esr, jaw or tongue claudication with or without visual loss 3. participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by gca (this will be made clear in the ethics approval application) exclusion criteria: 1. previous diagnosis of gca 2. long term (\>1 month) high dose (\>20mg per day at any time) steroids for conditions other than pmr, within three months prior to study entry 3. inability to give informed consent (either written consent or verbal assent from a relative or carer)

Keywords: vasculitis autoimmune disease connective tissue disease polymyalgia rheumatica musculoskeletal diseases immune disorder rheumatic disease
study to assess the efficacy of a cholesterol lowering drug on top of statins in patients after myocardial infarction (mi)(0653a-150)

Conditions: Cardiovascular Disorder

Summary: collecting local data, safety and experience trial.


Eligibility criteria:
inclusion criteria: * patients; post acute coronary syndrome exclusion criteria: -
use of botulinum toxin to treat psoriasis

Conditions: Psoriasis Vulgaris

Summary: psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation. recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions. this pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.


Eligibility criteria:
inclusion criteria: * healthy subjects. psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. in addition, the subject should have at least a score of 2 for keratoderma and erythema. signed informed consent. willing to adhere to protocol. exclusion criteria: * immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.

Keywords: psoriasis botulinum toxin
four-drug combination treatment in hiv-infected subjects failing therapy with antiretroviral regimens

Conditions: HIV Infections

Summary: this is a 48 week study for hiv-infected patients who have failed several regimens including pi's, nnrts and nrtis. patients will be randomly selected to be in 1 of 4 groups. three of the 4 groups will contain capravirine in different doses combined with kaletra and nucleosides and one of the groups will be a combination of kaletra and nucleosides without the capravirine.


Eligibility criteria:
inclusion criteria: * hiv-infected male or female at least 18 years of age * hiv rna level \>1000 copies/ml at screening * subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors * adequate renal function * adequate hematological function * adequate liver function exclusion criteria: * women who are pregnant or lactating * no previous experience with kaletra
levonorgestrel-releasing intrauterine device on obese women: effects on hemostatic and arterial function

Conditions: Contraception Desired; Obesity

Summary: obesity is a disorder associated with metabolic dysfunction and changes in cardiovascular risk markers; the use of oral contraceptives (ocs) may exert a further negative effect on these alterations in patients with pcos. to assess the effects on arterial function and structure and hemostatic parameters using an levonorgestrel intrauterine device (ius-lng) in women with obesity a randomized controlled clinical trial.

setting: academic hospital. 88 women between 18 and 40 years of age with obesity (bmi between 20 and 40 kg/m2)randomized to use ius-lng or copper-iud for 12 months exclusion criteria: category 3 and 4 medical eligibility criteria for iud-cu and ius-lng - who-2010, pregnancy, lactation, concomitant drugs, smoking. main outcome measures: brachial artery flow-mediated vasodilation, carotid intima-media thickness and the carotid artery stiffness index were evaluated at baseline and after 6 and 12 months. serum markers of cardiovascular disease and hemostatic parameters will be also analyzed.

Eligibility criteria:
inclusion criteria: * women 18 to 40 years of age with obesity grade i and ii who wished to use a contraceptive exclusion criteria: * any clinical conditions corresponding to category 3 or 4 of the world health organization medical eligibility criteria for iud-lng or iud-cu use smoking * alcoholism * illicit drug use * any systemic disease (systemic arterial hypertension, dm, immune system diseases or thyroid diseases) except pcos * current or previous (up to two months before the study) use of oral, vaginal, monthly injectable or transdermal combined hormonal contraceptives current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant or intrauterine device) * twelve weeks or less since childbirth * currently breastfeeding or had stopped breastfeeding within two months of the screening visit * chronic and/or acute inflammatory processes * use of drugs known to interfere with inflammatory markers or with cvd risk (anti-androgens, hypoglycemic drugs, anti-inflammatory drugs or statins)

Keywords: obesity contraceptives hormonal levonorgestrel-releasing intrauterine device cardiovascular risk
retention in hiv care for hispanic immigrants

Conditions: HIV/AIDS

Summary: a randomized trial to test the feasibility and acceptability of an intervention to improve retention in hiv primary care in hiv-infected hispanic immigrants compared to a "treatment as usual" condition. we will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. the intervention design is based on qualitative research with hiv-infected hispanic immigrants and their hiv providers. the intervention will be led by a spanish-speaking community health worker trained in hiv health promotion.

overview: participants will be hiv-infected hispanic immigrants age ≥18 years. participants will be recruited from partners-affiliated infectious disease and primary care clinics as well as clinics and community-based organizations in the greater boston area with high contact with hiv-infected hispanics. in the intervention, a bilingual (english-spanish speaking) community health worker (chw) will deliver personalized sessions framed around a spanish-language multi-media health communication tool. the chw will deliver the intervention over a 16 to 24 week period. study procedures: participants will be hiv-infected hispanic immigrants age ≥18 years at risk for inconsistent attendance (as measured during study screening). participants will be recruited via provider referral, peer referral, flyers, and social media. once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline survey. after completion of the baseline survey, study staff will randomize participants into a treatment as usual (tau) group or intervention group. at trial exit, all participants, including the tau group, will complete an in-depth assessment to measure their barriers to hiv care and provide feedback about their experience in the study.

Eligibility criteria:
inclusion criteria: * age 18 years or older and able to communicate in spanish or english * born in puerto rico or spanish-speaking latin american country * hiv-infected or hiv-positive * new hiv diagnosis or unable to regularly attend hiv primary care appointments exclusion criteria: * unable to provide verbal consent due to unstable medical or psychiatric condition
home jejunostomy feeding following esophagectomy/gastrectomy

Conditions: Esophageal Neoplasms

Summary: after surgery for oesophageal (gullet) or gastric (stomach) cancer, patients are routinely fed by means of a small feeding tube into the intestine (jejunostomy, jej) while they are in hospital. current practice is to stop feeding once the patient leaves hospital, although the tube is left in place for the first 6 weeks. most patients lose weight after surgery and have to learn to adjust to new eating habits and behaviours. a few patients have the jej feed restarted because of nutritional problems and this requires a further inpatient stay. it is unknown whether every patient would benefit from this type of feeding at home. previous studies have only assessed the value of jej feeding while patients are still in hospital. there is little known about the benefit of continuing jej feeding after discharge from hospital, although home feeding is not uncommon in other patient groups (eg. after a stroke). the proposed study will provide initial information on patients' well being by measuring quality of life and factors such as change in body weight and dietary intake following a period of home jej feeding after surgery. subjects recruited into the study will be placed, randomly, into a control group who receive current nutritional care (based on dietary advice and oral nutritional supplement drinks) or an intervention group who will receive home jej feeding for 6 weeks after hospital discharge, in addition to current treatment. if subjects in the control group are experiencing problems eating at home, home feeding through the jej tube will be started as needed. the study will also examine how surgery and jej feeding at home impact on the patient and carer(s) by means of questionnaires and interviews conducted in the patients' home. information obtained will assist in the design of a multicentre study. this intervention is considered important because it has the potential to benefit thousands of patients each year at a modest cost.


Eligibility criteria:
inclusion criteria: * planned esophagectomy or total gastrectomy for adenocarcinoma or squamous carcinoma * suitable for home enteral nutrition exclusion criteria: * inability to provide written informed consent

Keywords: randomized jejunostomy enteral nutrition esophagectomy gastrectomy
prognostic value of functional exercise test (efx) in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the objective of study is to prospectively determine if cpet with blood gas analysis should have a prognostic value in cf. the study plans to include 300 cystic fibrosis patients. inclusion criteria will be: age \>15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before cpet. patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. the study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with dlco (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. the results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the cpet abnormalities.

current guidelines for referring cystic fibrosis (cf) patients for lung transplantation, based on clinical and functional resting parameters, are insufficient to predict 3-year mortality. previous studies have shown that sex, impaired pulmonary function, undernutrition and colonization of the respiratory tract by pseudomonas aeruginosa are associated with a poor prognosis. current guidelines for referral to a lung transplant center include age, sex, forced expiratory volume at one second (fev1) below 30% predicted or a rapid decline of fev1, in particular in young female patients, increasing frequency of exacerbations requiring antibiotic therapy, refractory or recurrent pneumothorax, recurrent hemoptysis not controlled by embolization. but, despite these criteria, near that 30% of patients are still dying while on the lung transplant waiting list, or are transplanted in high emergency. cardiopulmonary exercise testing (cpet) in cf patients would have an interest in the following of cystic fibrosis patients. a previous study, carried out on fifty one adult patients, showed that cpet with blood gas analysis may have a prognosis value in cystic fibrosis. the authors found that a bmi \ 43 mmhg were independently associated with a lower chance of survival.

Eligibility criteria:
inclusion criteria: * age more than 15 years * cystic fibrosis diagnosed by positive sweat chloride test or genetic test exclusion criteria: * pregnant or breastfeeding woman * waiting on transplantation list

Keywords: cystic fibrosis cardiopulmonary exercise testing prognostic
validation of a creation health assessment tool for patients in a diabetic outpatient population

Conditions: Type 2 Diabetes Mellitus

Summary: participants will complete a survey before an educational session, during the "break" of an educational session, or after the session.

participants will be recruited from diabetes education sessions at selected locations and at fhmg physician practices. for the diabetes education setting, ta research team member will introduce this study to a group of patients before educational sessions, during "break" of the educational sessions, and after sessions. if the patient is interested, an envelope with the invitation to participant letter attached to it and the survey enclosed will be given to them. also, a note will be attached to the envelope with the instructions: "please drop your completed survey in the drop-box at ___." the drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally. for patients at physician practices, an envelope with the invitation to participant letter attached to it and survey enclosed will be given by a staff member. invitation to participant letter contains all portions of the consent process. a note will be attached to the envelope with the instructions: "please drop your completed survey in the drop box at____." the drop-box location will be identified within each setting and provided to the participants in the note or indicated verbally. if patient does not meet the inclusion criteria, they will be asked to return the envelope to the staff member who provided it. patients will be provided with invitation to participate letter along with survey. the invitation to participate letter provides patients with study details including inclusion/exclusion criteria, duration of participation, procedures to ensure confidentiality, and an overview of voluntary participation conditions. implied consent will be used. in addition to the invitation to participate letter, there is a statement at the top of the survey "return of completed surveys implies consent to participate in the study"

Eligibility criteria:
inclusion criteria: 1. age 18 and above 2. diagnosis of type ii diabetes 3. able to speak and understand english 4. able to provide informed consent exclusion criteria: 1. children under 18 2. does not speak or understand english 3. not of cognitive capacity to provide valid responses 4. prisoners

Keywords: diabetes type 2 diabetes diabetes mellitus type 2 diabetes mellitus outpatient
a study of mk2578 in patients with chronic kidney disease who are not on dialysis (2578-002)

Conditions: Anemia; Chronic Kidney Disease

Summary: this study will define an effective starting dose for subcutaneous administration of mk2578 to correct anemia in erythropoiesis-stimulating agent (esa)-naive patients with chronic kidney disease (ckd) who are not on dialysis while evaluating its safety.


Eligibility criteria:
inclusion criteria: * patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures * patient has chronic kidney disease exclusion criteria: * patient is morbidly obese * patient has used another erythropoiesis (red blood cell formation) stimulating agent within 12 weeks of screening * patient will require dialysis during the study or is planning to have a kidney transplant within the next 6 months * patient has had a blood transfusion within 12 weeks of screening * patient has had major surgery within the past 12 weeks or plans to have surgery * patient has human immunodeficiency virus (hiv) * patient has a history of diseases other than ckd known to cause anemia * patient has severe congestive heart failure * patient has history of malignant cancer, except certain skin or cervical cancers * patient has a history of grand mal seizures within the last 6 months * patient is pregnant or breastfeeding

Keywords: anemia